THE OPPORTUNITY: Reporting to the Head of Biometrics the Director of Biostatistics oncology provides technical leadership and biostatistical support to Vir Clinical Development programs focused on oncology. You will be the statistical lead on one or more drug development projects and act as a statistical expert across all project studies, working collaboratively with clinicians, data managers, biostatisticians and statistical programmers. You will use your project management and leadership skills in the planning, conduct, and analysis of clinical trials.
This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.
WHAT YOU'LL DO: As a biostatistics expert for VIR clinical oncology programs you will provide strategic input to optimize trial designsYou will work with internal and external statistical programming team members on the planning and execution of statistical deliverablesConduct statistical simulations to ensure robust and efficient statistical designs and address identified or potential statistical issues arising with studiesContribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principlesAuthor or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverablesReview electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analysesPerform QC/QA of statistical deliverables including validation of main analysis resultsContribute to clinical study reports, including authoring of statistical methods, and interpretation of study resultsAccountable for assigned statistical activities to support IND/NDA/MAA or other regulatory submissions; provide review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documentsAddress statistical questions/comments from FDA and other regulatory agencies, or IRB/ECsLead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standardsRepresent VIR regarding statistical issues in meetings with external parties including regulatory agencies and corporate partnersSupport inspection readiness activitiesWHO YOU ARE AND WHAT YOU BRING: PhD. in Biostatistics and 10+ years of relevant work experience, or M.S. in Biostatistics and 13+ years of relevant work experienceHands-on Experience in INDs, NDAs, MAAs, or other regulatory submissionsIn-depth knowledge of statistical methods for clinical trialsKnowledge of FDA, EMA, and ICH regulations and guidelinesProficient in statistical programming (SAS and R)Experience leading statistical efforts for multiple studiesFluent in data standards, including SDTM and ADaMExperience with outsourced statistical services provided by CROs#LI-225024411_AA1
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WHO WE ARE AND WHAT WE OFFER: The expected salary range for this position is $207,500 to $284,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all on-site employees.
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